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Completed

NCT Number: NCT06366295

Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial

The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

About this study

Non-surgical treatment is the basic form of disease treatment periodontitis. Its first stage is the mechanical removal of dental plaque along with the control of risk factors. Subgingival mechanotherapy, also known as scaling and root planing (SRP) is the next stage, aimed at the subgingival area. Perioscopy makes possible direct real-time visualization of the root surface during the procedure. The research results published so far indicate improvement or no significant differences clinical parameters after SRP procedure using a perioscope vs traditional subgingival instrumentation. The aim of this study is to indicate, or not, clinical, biochemical (level of pro-inflammatory cytokines) and microbiological (A. actinomycetemcomitans, P. gingivalis, T. denticola) differences after periodontitis treatment using the traditional method vs. using a perioscope.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 20-60; (II)
  • preserved lateral and anterior teeth;
  • no periodontal treatment in the last 12 months;
  • intermediate or advanced periodontitis (Stage II / III / IV)
  • in each quadrant at least three teeth with PPD>5 mm after initial treatment (scaling, motivation, instruction)

Exclusion criteria

  • antibiotic therapy in the last 6 months;
  • smoking;
  • systemic diseases affecting periodontal tissues;
  • pregnancy or lactation;
  • orthodontic treatment;
  • tooth mobility II / III degree;
  • involvement of third degree furcations according to Hamp classification;
  • endodontic issues

Treatment and study plan

subgingival mechanotherapy with perioscopy

Device

Subgingival mechanotherapy using a machine scaler, curettes and a perioscope

classical subgingival mechanotherapy

Device

Subgingival mechanotherapy using a machine scaler and curettes

Primary outcomes

  1. Probing pocket depth (PPD)

    Time frame: 0 (before), 3 and 6 months after SRP

    Distance from the gingival margin to the bottom of the gingival sulcus

  2. Clinical attachment level (CAL)

    Time frame: 0 (before), 3 and 6 months after SRP

    Distance from the cementoenamel junction to the bottom of the gingival sulcus

  3. Bleeding on probing (BoP)

    Time frame: 0 (before), 3 and 6 months after SRP

    Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.

  4. Plaque index (PI)

    Time frame: 0 (before), 3 and 6 months after SRP

    Percentage of sites with plaque

Secondary outcomes

  1. Width of keratinized tissue (KTW)

    Time frame: 0 (before), 3 and 6 months after SRP

    Distance between the most apical point of gingival margin and the mucogingival junction

  2. Gingival thickness (GT)

    Time frame: 0 (before), 3 and 6 months after SRP

    Thickness of the gingiva measured 2 mm apical to the gingival margin

Other outcomes

  1. Subgingival plaque pathogens (Aa, Pg, Td) levels

    Time frame: 0 (before) and 6 months after SRP

    Levels of periodontal pathogens (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola) measured with real-time polymerase chain reaction (RT-PCR) test; data presented as number of bacteria of these species and percentage of total bacteria found in a sample; sample taken from the deepest pocket on each side.

  2. Gingival crevicular fluid levels of cytokines

    Time frame: 0 (before), 3 and 6 months after SRP

    Levels of (IL - interleukin) IL-1β, IL-6, IL-8, IL-10 and interferon-gamma in gingival crevicular fluid presented as pg/ml; sample taken from the deepest pocket on each side.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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